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AAMI/ISO/IEC Guide 63:2019

Guide to the development and inclusion of aspects of safety in International Standards for medical devices
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AAMI/ISO/IEC Guide 63:2019

Guide to the development and inclusion of aspects of safety in International Standards for medical devices

PUBLISH DATE 2019
AAMI/ISO/IEC Guide 63:2019
This document provides requirements and recommendations to writers of medical device standards on the inclusion of aspects related to safety in International Standards, based on well-established risk management concepts and methodology. This document is applicable to any aspect related to the safety of people, property, the environment, or a combination of these. In this document, the term “product” includes a medical device or a system consisting of one or more medical devices, possibly combined with non-medical devices.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number AAMI/ISO/IEC Guide 63
Publication Date Dec. 22, 2019
Language en - English
Page Count 38
Revision Level
Supercedes
Committee
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